DONALD BRANDT, 77, and SHARON BRANDT, 65, of Mount Vernon, Washington, were indicted yesterday by a federal grand jury in Seattle in connection with their purchase and use of unapproved and misbranded medical devices at their clinic in Mount Vernon. The official charges are: Conspiracy to Cause the Introduction into Interstate Commerce with the Intent to Defraud or Mislead One or More Misbranded Medical Devices and One or More Adulterated Medical Devices; Causing the Introduction of Misbranded Medical Devices into Interstate Commerce with Intent to Defraud or Mislead; and Receipt of an Adulterated Medical Device through Interstate Commerce with Intent to Defraud or Mislead. The charges are punishable by up to three years in prison.

According to the indictment, between at least 2002 and 2005, the BRANDTs operated a clinic on Blodgett Road in Mount Vernon, Washington. The clinic claimed to provide medical treatments and sold nutritional supplements. DONALD BRANDT allegedly “treated” patients, even though he had no medical license or degree. SHARON BRANDT was in charge of scheduling appointments. The couple ordered Multi-Function Wave Form Generators, an Electro-Acuscope Model 70-C, and a Vibe Machine for use at the clinic. Neither the Wave Form Generators nor the Vibe machine had been approved for use by the Food and Drug Administration. The Electro-Acuscope had been approved for use, but only by or under the supervision of trained medical professionals. When DONALD BRANDT ordered the devices he allegedly told the companies he was a medical doctor. The one approved device, was approved for use by medical personnel, for the treatment of pain.

The couple allegedly promoted use of the machines as a treatment for a variety of illnesses including hepatitis and cancer. SHARON BRANDT allegedly told patients and their family members to “Keep quiet” about the treatments or the clinic would be in trouble with the FDA.

The couple will make their initial appearance on the charges in U.S. District Court in Seattle on January 3, 2008.

The charges contained in the indictment are only allegations. A person is presumed innocent unless and until he or she is proven guilty beyond a reasonable doubt in a court of law.

The case is being investigated by the FDA and the Washington State Department of Health.

The case is being prosecuted by Assistant United States Attorney Susan Loitz.

For additional information please contact Emily Langlie, Public Affairs Officer for the United States Attorney’s Office, at (206) 553-4110.